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Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
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http://www.clinicaltrials.gov/ct2/show/NCT01260350?term=gs5885&rank=11
GS-9669, A Novel NS5B Non-Nucleoside Thumb Site II Inhibitor, Demonstrates Potent Antiviral Activity, Favorable Safety Profile and Potential for Once-Daily
http://www.natap.org/2012/EASL/EASL_48.htm
Antiviral Activity and Resistance Profile of the Novel HCV NS5A Inhibitor GS-5885
http://www.natap.org/2012/EASL/EASL_62.htm
Three-Day, Dose-Ranging Study of the HCV NS5A Inhibitor GS-5885
http://www.natap.org/2011/EASL/EASL_68.htm
Detailed Description:
Part 1: PSI-7977 400 mg QD with weight-based RBV for 12 weeks. Subjects will be randomized in equal proportions to: no PEG-IFN (Arm 1), PEG-IFN for 4 weeks (Arm 2), PEG-IFN for 8 weeks (Arm 3), or PEG-IFN for 12 weeks (Arm 4); Part 2: HCV GT 2/3 patients receive PSI-7977 400 mg QD monotherapy for 12 weeks (Arm 5), or PSI-7977 400 mg QD with PEG-IFN and weight-based RBV for 8 weeks (Arm 6), and HCV GT1 null-responders receive PSI-7977 400 mg QD with weight-based RBV for 12 weeks (Arm 7); Part 3: HCV GT-1 treatment naive (Arm 8) or HCV GT 2/3 treatment experienced subjects (Arm 9) receive PSI-7977 400 mg QD in combination with weight-based RBV for 12 weeks; Part 4: HCV GT-2/3 treatment naive subjects receive PSI-7977 400 mg QD with weight-based RBV for 8 weeks (Arm 10) or PSI-7977 400 mg QD and 800 mg RBV for 12 weeks (Arm 11). HCV GT-1 "null response" subjects receive PSI-7977 400 mg QD, GS-5885, and weight based RBV for 12 weeks (Arm 12). HCV GT-1 treatment naive subjects receive PSI-7977 400 mg QD with weight-based RBV and GS-5885 for 12 weeks (Arm 13); Part 5: HCV GT 1 "null response" subjects receive PSI-7977 400 mg QD with GS-9669 500 mg QD and weight-based RBV for 12 weeks (Arm 14). HCV GT-1 treatment naive subjects receive PSI-7977 400 mg QD with GS-9669 500 mg QD and weight-based RBV for 12 weeks (Arm 15).
Part 6: HCV GT-1 "null response" subjects with fibrosis stage F4 receive sofosbuvir/GS-5885 FDC for 12 weeks (Arm 16) or sofosbuvir/GS-5885 FDC with weight-based RBV for 12 weeks (Arm 17). HCV GT-2/3 treatment naive subjects receive sofosbuvir/GS-5885 FDC for 12 weeks (Arm 18). HCV GT-2/3 treatment-experienced subjects receive sofosbuvir/GS-5885 FDC for 12 weeks (Arm 19). HCV GT-1 hemophiliacs receive sofosbuvir/GS-5885 FDC with weight-based RBV for 12 weeks (Arm 20). HCV GT-1 treatment-naive subjects receive sofosbuvir/GS-5885 FDC with weight-based RBV for 6 weeks (Arm 21). HCV GT-1 treatment-naive subjects receive sofosbuvir/GS-5885 FDC for 6 weeks (Arm 22).
Experimental: Arm 21: Sofosbuvir/GS-5885 FDC and RBV
Sofosbuvir/GS-5885 FDC and weight-based RBV for 6 weeks in GT-1 treatment naive subjects
Experimental: Arm 22: Sofosbuvir/GS-5885 FDC
Sofosbuvir/GS-5885 FDC for 6 weeks in GT-1 treatment naive subjects
Experimental: Arm 14: PSI-7977, RBV, GS-9669
PSI-7977 400 mg QD, weight-based RBV and GS-9669 for 12 weeks in GT-1 null responders
Experimental: Arm 16: Sofosbuvir/GS-5885 FDC
Sofosbuvir/GS-5885 FDC for 12 weeks in GT-1 prior null responders with cirrhosis
Experimental: Arm 17: Sofosbuvir/GS-5885 FDC and RBV
Sofosbuvir/GS-5885 FDC and weight-based RBV for 12 weeks in GT-1 prior null responders with cirrhosis
Experimental: Arm 18: Sofosbuvir/GS-5885 FDC
Sofosbuvir/GS-5885 FDC for 12 weeks in GT-2/3 treatment naive subjects
Experimental: Arm 19: Sofosbuvir/GS-5885 FDC
Sofosbuvir/GS-5885 FDC for 12 weeks in GT-2/3 treatment experienced subjects
Experimental: Arm 20: Sofosbuvir/GS-5885 FDC and RBV
Sofosbuvir/GS-5885 FDC and weight-based RBV for 12 weeks in GT-1 Hemophiliacs
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